Abstract
1. Cochrane Database Syst Rev. 2018 Oct 17;10:CD010318. doi:
10.1002/14651858.CD010318.pub3.
Negative pressure wound therapy for treating foot wounds in people with diabetes
mellitus.
Liu Z(1), Dumville JC, Hinchliffe RJ, Cullum N, Game F, Stubbs N, Sweeting M,
Peinemann F.
Author information:
(1)West China School of Public Health, West China Hospital, Sichuan University,
Chengdu, Sichuan, China, 610041.
Update of
Cochrane Database Syst Rev. 2013 Oct 17;(10):CD010318.
BACKGROUND: Foot wounds in people with diabetes mellitus (DM) are a common and
serious global health issue. People with DM are prone to developing foot ulcers
and, if these do not heal, they may also undergo foot amputation surgery
resulting in postoperative wounds. Negative pressure wound therapy (NPWT) is a
technology that is currently used widely in wound care. NPWT involves the
application of a wound dressing attached to a vacuum suction machine. A carefully
controlled negative pressure (or vacuum) sucks wound and tissue fluid away from
the treated area into a canister. A clear and current overview of current
evidence is required to facilitate decision-making regarding its use.
OBJECTIVES: To assess the effects of negative pressure wound therapy compared
with standard care or other therapies in the treatment of foot wounds in people
with DM in any care setting.
SEARCH METHODS: In January 2018, for this first update of this review, we
searched the Cochrane Wounds Specialised Register; the Cochrane Central Register
of Controlled Trials (CENTRAL); Ovid MEDLINE (including In-Process & Other
Non-Indexed Citations); Ovid Embase and EBSCO CINAHL Plus. We also searched
clinical trials registries for ongoing and unpublished studies, and scanned
reference lists of relevant included studies, reviews, meta-analyses and health
technology reports to identify additional studies. There were no restrictions
with respect to language, date of publication or study setting. We identified six
additional studies for inclusion in the review.
SELECTION CRITERIA: Published or unpublished randomised controlled trials (RCTs)
that evaluated the effects of any brand of NPWT in the treatment of foot wounds
in people with DM, irrespective of date or language of publication. Particular
effort was made to identify unpublished studies.
DATA COLLECTION AND ANALYSIS: Two review authors independently performed study
selection, risk of bias assessment and data extraction. Initial disagreements
were resolved by discussion, or by including a third review author when
necessary. We presented and analysed data separately for foot ulcers and
postoperative wounds.
MAIN RESULTS: Eleven RCTs (972 participants) met the inclusion criteria. Study
sample sizes ranged from 15 to 341 participants. One study had three arms, which
were all included in the review. The remaining 10 studies had two arms. Two
studies focused on postamputation wounds and all other studies included foot
ulcers in people with DM. Ten studies compared NPWT with dressings; and one study
compared NPWT delivered at 75 mmHg with NPWT delivered at 125 mmHg. Our primary
outcome measures were the number of wounds healed and time to wound healing.NPWT
compared with dressings for postoperative woundsTwo studies (292 participants)
compared NPWT with moist wound dressings in postoperative wounds (postamputation
wounds). Only one study specified a follow-up time, which was 16 weeks. This
study (162 participants) reported an increased number of healed wounds in the
NPWT group compared with the dressings group (risk ratio (RR) 1.44, 95%
confidence interval (CI) 1.03 to 2.01; low-certainty evidence, downgraded for
risk of bias and imprecision). This study also reported that median time to
healing was 21 days shorter with NPWT compared with moist dressings (hazard ratio
(HR) calculated by review authors 1.91, 95% CI 1.21 to 2.99; low-certainty
evidence, downgraded for risk of bias and imprecision). Data from the two studies
suggest that it is uncertain whether there is a difference between groups in
amputation risk (RR 0.38, 95% CI 0.14 to 1.02; 292 participants; very
low-certainty evidence, downgraded once for risk of bias and twice for
imprecision).NPWT compared with dressings for foot ulcersThere were eight studies
(640 participants) in this analysis and follow-up times varied between studies.
Six studies (513 participants) reported the proportion of wounds healed and data
could be pooled for five studies. Pooled data (486 participants) suggest that
NPWT may increase the number of healed wounds compared with dressings (RR 1.40,
95% CI 1.14 to 1.72; I² = 0%; low-certainty evidence, downgraded once for risk of
bias and once for imprecision). Three studies assessed time to healing, but only
one study reported usable data. This study reported that NPWT reduced the time to
healing compared with dressings (hazard ratio (HR) calculated by review authors
1.82, 95% CI 1.27 to 2.60; 341 participants; low-certainty evidence, downgraded
once for risk of bias and once for imprecision).Data from three studies (441
participants) suggest that people allocated to NPWT may be at reduced risk of
amputation compared with people allocated to dressings (RR 0.33, 95% CI 0.15 to
0.70; I² = 0%; low-certainty evidence; downgraded once for risk of bias and once
for imprecision).Low-pressure compared with high-pressure NPWT for foot ulcersOne
study (40 participants) compared NPWT 75 mmHg and NPWT 125 mmHg. Follow-up time
was four weeks. There were no data on primary outcomes. There was no clear
difference in the number of wounds closed or covered with surgery between groups
(RR 0.83, 95% CI 0.47 to 1.47; very low-certainty evidence, downgraded once for
risk of bias and twice for serious imprecision) and adverse events (RR 1.50, 95%
CI 0.28 to 8.04; very low-certainty evidence, downgraded once for risk of bias
and twice for serious imprecision).
AUTHORS' CONCLUSIONS: There is low-certainty evidence to suggest that NPWT, when
compared with wound dressings, may increase the proportion of wounds healed and
reduce the time to healing for postoperative foot wounds and ulcers of the foot
in people with DM. For the comparisons of different pressures of NPWT for
treating foot ulcers in people with DM, it is uncertain whether there is a
difference in the number of wounds closed or covered with surgery, and adverse
events. None of the included studies provided evidence on time to closure or
coverage surgery, health-related quality of life or cost-effectiveness. The
limitations in current RCT evidence suggest that further trials are required to
reduce uncertainty around decision-making regarding the use of NPWT to treat foot
wounds in people with DM.
DOI: 10.1002/14651858.CD010318.pub3
PMID: 30328611